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Terminated

Exactech Tibial Augmentation Block Trial Size 0, Exactech Tibial Tray Trial size 1 Delta and Exactech Trapezoid Tray Trial size 1 Delta.

FDA Recall Z-1211-03 · Posted 2003-09-11

Recalling FirmExactech, Inc.
Recall StatusTerminated
Product CodeLXH
Date Initiated2003-08-01
Date Terminated2012-05-03
Product Quantity169

Reason for Recall

Misalignment of the fixation holes between the tibial augment block trials and the corresponding tibial tray trials and trapezoid tray trials. The misalignment of the pin fixation holes only creates an issue when augmentation is used.

Firm Action

A recall letter dated July 31, 2003, requesting return of certain Tibial Augmentation Block Trials and an advisory (Field Advisory K-078) on the use of certain Tibial Tray Trials and Trapezoid Tibial Tray Trials. The recall letter gives the address to return product as: Exactech, 2243 NW 66th Court, Gainesville, FL. Consignees were told to immediately cease distribution or use of the recalled products and to return them. Also the letter asks them to extend the recall information to their user accounts and to read and comply with the instructions provided in the attached 'Field Advisory K-078'. This advisory instructs the dealers and users on the use of the devices to avoid problems.

Root Cause

Other

Distribution Pattern

Nationwide. Also the products were distributed to three intenational accounts in Spain, Japan and China.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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